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Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy.

13 oktober 2026 uppdaterad av: Saoussen Layouni, Faculty of Medicine, Sousse

Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy: A Randomized Controlled Trial.

Cerebral palsy (CP) causes persistent motor and postural impairments that can limit children's functional independence and participation. Upper-limb rehabilitation traditionally relies on conventional therapies, while Virtual Reality (VR) provides an immersive, engaging environment that can improve motor function and quality of life. Constraint-Induced Movement Therapy (CIMT) promotes intensive use of the affected upper limb and has demonstrated benefits in motor and functional outcomes. Recent evidence suggests that combining VR with CIMT (VRCIT) may further improve upper-limb function, hand manipulation, and dexterity. However, in Tunisia, access to CIMT and VR-based rehabilitation remains limited, and no Tunisian study has yet evaluated the effectiveness of VRCIT in children with unilateral CP, highlighting an important research gap.

Aim: Evaluate the effectiveness of Virtual Reality-Augmented Constraint-Induced Movement Therapy and constraint-induced movement therapy only in improving unimanual upper limb function in children with unilateral cerebral palsy.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Beräknad)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

4 år till 14 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Able to handle objects in daily life within levels I, II and III on the Gross Motor Function Classification System.
  • Absence of musculoskeletal disorders that impaired the ability of children to use the VR system.
  • Normal or corrected hearing and vision.
  • Able to understand and follow simple directions and perform requested tasks.
  • Tutor Consent.

Exclusion Criteria:

  • Dizziness during VR sessions.
  • Intolerance to VR environments.
  • Unable to continue or follow the CIMT or VR program.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 30 children between 5 to 14 years diagnosed with spastic hemiplegic cerebral palsy.

All participants will undergo two assessment sessions, one at baseline and one at the end of the program.

Clinical testing will consist of physical examination, assessing unimanual function through the Melbourne Assessment 2 (MA2), unilateral gross manual dexterity (The Box and blocks Test), spasticity through the Modified Ashworth Scale (MAS) for elbow and wrist, muscle strength grading (MRC), upper limb passive range of motion (PROM), and bimanual ability through ABILHANDS-KIDS questionnaire.

The clinical outcome measures will be recorded by a researcher-resident in physical medicine and rehabilitation.

After obtaining the oral consent of the participants' legal guardians, those who met the inclusion criteria will be divided in two groups: The first group will receive a CIMT program, the second group will undergo a VRCIT based-rehabilitation program, both for a period of two weeks. A clinical evaluation will be performed one day before the program.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The Melbourne Assessment 2 (MA2)
Tidsram: before and immediately after the intervention

The Melbourne Assessment 2 (MA2) is a standardized assessment tool used to evaluate the quality of unilateral (one-sided) upper limb function in children with neurological impairments. It focuses on assessing the range of movement, accuracy, dexterity, and fluency of the child's upper limb during specific tasks.

It reports a child's performance as four separate percentage scores corresponding to each measured element of movement quality.

before and immediately after the intervention

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Spasticity
Tidsram: before and immediately after intervention

Spasticity through the Modified Ashworth Scale (MAS) for elbow and wrist ranging from 0 (normal tone) to 4 (rigid).

before and immediately after intervention
Muscle strength
Tidsram: before and immediately after intervention

Muscle strength grading (MRC) ranging from 0 (no muscle activation) to 5 (normal muscle strength with full power against maximal resistance and a complete range of motion).

before and immediately after intervention
Passive Range of Motion
Tidsram: before and immediately after intervention

Upper limb passive range of motion (PROM) in degrees measured with a goniometer.

before and immediately after intervention
The Box and Blocks Test
Tidsram: before and immediately after intervention

Unilateral gross manual dexterity (The Box and blocks Test) for the affected limb scored by counting the total number of blocks safely transferred from one compartment to the other in 60 seconds (number of blocks per minute).

before and immediately after intervention
ABILHANDS-KIDS questionnaire
Tidsram: before and immediately after intervention

Bimanual ability to manage daily life activities through ABILHANDS-KIDS questionnaire ranging from 0 to 42, with each task is assessed as "easy", "difficult" or "impossible". Raw scores are converted through a psychometric analysis (Rasch model) into a linear measure in logits on a continuous scale.

Higher score: Indicates a better manual ability and greater independence in daily life activities requiring the use of both hands.

Lower score: Reveals a significant activity limitation and an increased need for assistance in personal care.

before and immediately after intervention

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Studieavstämningsdatum

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Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

30 januari 2027

Avslutad studie (Beräknad)

28 februari 2027

Studieregistreringsdatum

Först inskickad

21 september 2026

Först inskickad som uppfyllde QC-kriterierna

26 september 2026

Första postat (Faktisk)

2 oktober 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 oktober 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • Department of PMR Sousse

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